Raltegravir and Maraviroc, the first in class of 2 new families of antiretroviral drugs have demonstrated a high potency in treatment experienced and naive patients. Both drugs appeared well tolerated with low metabolic toxicity. No data are currently available concerning the combination of these 2 drugs.

To establish the ability of a Maraviroc-Raltegravir combination to maintain HIV-1 viral load < 50 copies/ml at week 48 in naive patients infected by CCR5 HIV-1, following an initial 6 month phase of Maraviroc-Raltegravir-Tenofovir-Emtricitabine combination (Intent to treat and strategy analysis)

To study CD4 progression from baseline to week 48

To study the time to virological failure during the simplification phase of the study (from week 24 to week 48)

To study the proportion of patients with HIV RNA < 50 copies/ml at each time point

To study the kinetics of viral load decrease from baseline to week 12

To study the kinetics of proviral DNA decrease from baseline to week 12, 24, 36 and 48

To study the clinical and biological tolerance of Maraviroc-Raltegravir combination through week 48

Study Design/ Clinical Plan

Pilot, multicenter, national, uncontrolled study

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Age ≥ 18 years old at the run-in visit

HIV-1 infection

Antiretroviral treatment-naive

CD4 ≥ 200 /mm3

HIV- RNA ≥ 1000 copies/ml

HIV-RNA ≤ 100,000 copies/ml

Antiretroviral therapy is indicated according to current guidelines

CCR5-tropic virus according to the Trofile ES® assayGeno2Pheno algorithm using a predefined false positive rate of 20%

No significant NRTI, NNRTI or PI resistance mutation

Freely-given, written, informed consent obtained; the patient and investigator have signed the consent form (by the latest on the day of the run-in visit and before performing any examinations required by the trial)

Patient covered by a French national health insurance scheme

Exclusion Criteria:

Women of child-bearing potential not using effective contraception (barrier method)

Pregnant or breast-feeding women

Patients under the age of 18 years

Patients deprived of liberty by a judicial or administrative, hospitalized patients without consent, patients admitted to a health or social purposes other than research

Persons major subject of a measure of legal protection or unable to consent

Previous antiretroviral therapy (with the exception of post-exposure prophylaxis if HIV serology is negative > 3 months after the last dose of antiretroviral drugs)

HIV-HBV co-infection. Patients with HIV-HCV co-infection are permitted to participate in the absence of decompensated cirrhosis (Child-Pugh class B or C), of hepatocytolysis > 3 times the upper limit of normal and if treatment for HCV during the ensuing 12 months is not indicated. PAtients with occult HBV are excluded.( positive AcHBc, negative AcHBs, negative AgHBs, positive HBV DNA)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01291459